1. Field of the Inventions
The present invention relates to a device for covering and applying a medicament to a protruding portion of a mammalian body. More specifically, the present invention relates to a flexible, continuous covering apparatus that surrounds the protruding body portion in order to protect it and/or retain a medical agent on it before or after an operation or other medical procedure has been performed.
2. Description of the Related Art
Certain medical procedures require that an agent, such as a medicament, be topically applied to, and maintained on, a portion of a patient's body. The need for the agent can arise before or after the medical procedures have been performed. These procedures can comprise patient examinations, minimally invasive diagnostic operations, exploratory operations and invasive therapeutic operations. The patient examinations may include the step of positioning a medical device, such as a probe, scope or catheter, within a body passageway to perform an examination or retrieve material from within the passageway or a related body cavity, such as a duct.
Topical anesthetics are an example of one class of medicaments that may be applied to the portion of the body hours before and/or after the intended procedure is performed. For example, topical anesthetics can prepare the body portion to receive a medical device that will be positioned within a body opening or incision during the procedure. A composition including an anesthetic and another active agent may also be used. In the situation where the composition is applied to a breast to prepare it for ductal access, a dekeratinizing agent and/or a ductal orifice dilating agent such as capsicum may be used. Agents applied post procedure might include topical antibiotics or well-known wound healing agents.
When the anesthetic is applied before the procedure, a cover, such as a bandage, is normally positioned over the anesthetic to prevent it from being prematurely wiped off. However, conventional covers do not offer the patient an effective option for covering the anesthetic for an hour or any other extended period of time that is sufficient to prepare (numb) the body portion. Instead, these covers lay like a flat drape, are normally ineffective and are uncomfortable to wear, especially when the patient is active between the time the anesthetic is applied and the procedure is performed. Hence, the patient may only wear the cover and the anesthetic for a short time before the procedure begins. Unfortunately, when this occurs, the amount of discomfort experienced by the patient during the procedure may be significantly increased.
Alternatively, the bandages can be wrapped circumferentially around the portion of the body being treated like an open ended cylinder if the treated portion is part or all of a protruding body member. However, these bandages do not cover, encapsulate and isolate the portion of the body from its normal environment. Examples of the protruding body portions that do not form effective seals with conventional bandages include, but are not limited to, nipples, fingers, toes, noses and pediatric penises.
When either of the conventional bandages is used on one of these protruding body portions, they cannot effectively cover and enclose the applied agent so that it does not leak out. Instead, the applied medicament may leak out from under the bandage and onto other parts of the patient including her clothing. This can result in less than a preferred amount of the agent remaining on the protruding body portion for the prescribed period of time. If enough leaks out from under the bandage, the overall effectiveness of the agent will be significantly reduced and the procedure may have to be postponed. If the procedure is not postponed, as discussed above, the patient may experience an unnecessary amount of pain and discomfort. When either circumstance occurs, the patient and the healthcare facility can become frustrated. If excessive amounts of the agent are applied in anticipation of some of it leaking out from under the bandage, the added amount may adversely effect the adhesive portion of the bandage and prevent any portion of it from adhering to the patient. If this occurs, the amount of the agent that will leak out from under the bandage will be excessive.
Other problems may also occur with the use of flat bandages. For example, it could be very embarrassing if the applied agent leaks out from under the bandage and stains the patient's shirt, pants, etc. The embarrassment may be enhanced depending on the location of the stain. Additionally, the cost of cleaning or replacing the garment that has been stained can be significant. These additional costs may frustrate the patient and possibly discourage her from having the same procedure or examination performed again. Moreover, problems and embarrassment can result if the stains cause other people to question their origin and learn about the procedure that the patient is about to undergo.
Covers for specific protruding body portions are well known. One such type of cover includes nipple covers for lactating nipples that permit expelled fluid to dry on the nipple. Examples of these covers are disclosed in U.S. Pat. No. 3,840,012, to Rushton, Jr., U.S. Pat. No. 5,032,103, to Larsson and French Patent No. 792,353, to Proquitte et al. These nipple covers include openings along their outer surface that permit air to enter the interior of the cover and dry any fluid expelled from the breast. As a result, these covers cannot be used to hold a medicament on a nipple. If they were, the medicament would leak out through the air hole(s) and onto the clothes of the patient. Therefore, the use of these covers would be pointless.
Other types of devices without ventilation holes are also used to cover nipples. One such nipple cover is used to cover the nipples of male long distance runners. Such a cover is disclosed in U.S. Pat. No. 5,743,272, to Kocher, Jr. Unlike the above-discussed covers for lactating nipples, the male nipple covers do not include ventilation openings. Instead, these covers have large, flat outer end surfaces. Additionally, these covers are not laterally or longitudinally flexible. As a result, they do not collapse around the nipple and conform to its shape. Therefore, others will readily notice these nipple covers when worm. This is not acceptable for women who need to wear a medicament containing nipple cover under their clothing during work or other activities in order to prepare their nipples for an examination or procedure such as ductal lavage. These nipple covers will be conspicuous and possibly embarrass the person using them because they can be easily seen under clothing when worn.